Label: STOMACH RELIEF- bismuth subsalicylate tablet, chewable
- NDC Code(s): 55301-319-01
- Packager: ARMY AND AIR FORCE EXCHANGE SERVICE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients (in each tablet)
Bismuth subsalicylate 262 mgClose
Upset stomach reliever/AntidiarrhealClose
- upset stomach
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Contains salicylate. Do not take if you are:
- allergic to salicylates (including aspirin)
- taking other salicylate products
Ask a doctor or pharmacist before use if you are
taking any drug for
- anticoagulation (thinning of the blood)
Stop use and ask a doctor if
- symptoms get worse
- ringing of the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- chew or dissolve in mouth
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed. Do not exceed 8 doses (16 tablets) in 24 hours.
- use until diarrhea stops, but not more than 2 days
- children under 12 years: ask a doctor
- Other information
- each tablet contains: calcium 40 mg, salicylate 102 mg
- store at controlled room temperature 15º-30ºC (59º-86ºF)
- avoid excessive heat
- store in a dry place
- see end flap for expiration date and lot number
- Inactive ingredients
calcium carbonate, cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, mannitol, povidone, sodium saccharin, stearic acid, talcClose
- Questions or comments?
- Principal Display Panel
Bismuth Subsalicylate 262 mg
Upset Stomach Reliever
Compare to The Active Ingredient of Pepto-Bismol®†
• Upset Stomach
†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Pepto-Bismol®.
SATISFACTION GUARANTEED OR YOUR MONEY BACK
Manufactured For: Your Military Exchanges
by: LNK International, Inc.
Hauppauge, NY 11788
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS BROKEN, TORN OR SHOWS ANY SIGNS OF TAMPERING
Exchange Select 44-319
- INGREDIENTS AND APPEARANCE
bismuth subsalicylate tablet, chewable
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55301-319 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE D&C RED NO. 27 D&C RED NO. 30 MAGNESIUM STEARATE MANNITOL SACCHARIN SODIUM STEARIC ACID TALC Product Characteristics Color PINK Score no score Shape ROUND Size 16mm Flavor CHERRY Imprint Code 44;319 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55301-319-01 5 in 1 CARTON 1 6 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part335 07/16/1998 Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(55301-319) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(55301-319)